| Abstract: |
Legislation of Radiopharmaceuticals is concerned with their radioactive nature and the related safety standards in handling them, but also, based on their definition as medicinal products in most countries worldwide both for diagnostic and therapeutic applications, with pharmaceutical regulations. This chapter covers the pharmaceutical regulations related to radiopharmaceuticals with a focus on the European legislation. It deals with the general pharmaceutical legislation and the process of marketing authorization allowing routine clinical application including besides radiopharmaceuticals also radionuclide generators, kits and radionuclide precursors. The regulatory framework related to Good Manufacturing Practices is described and the legal requirements contained in the European Pharmacopoeia dealing with quality standards are covered. The clinical trial regulation in Europe is described and finally the situation in the United States is summarized and national regulations and guidelines from professional organizations are addressed. © 2022 Elsevier Inc. All rights reserved. |
